There are numerous types of thermoregulatory devices that alter and/or maintain a patient's temperature. One type of thermoregulatory device is Gaymar's T-pad device which has been existence since at least 1985. Gaymar's T-pad thermoregulatory device has a first polymeric layer and a second polymeric layer. The first polymeric layer has a first interior surface and a first exterior surface. Likewise, the second polymeric layer has a second interior surface and a second exterior surface.
The perimeter of the first interior surface attaches and/or seals to the perimeter of the second interior surface to form an enclosure. The enclosure receives a fluid from a fluid regulatory device. An example of a fluid regulatory device is Gaymar's Medi-Therm fluid regulatory device. The fluid regulatory device contains and/or obtains a fluid. The fluid can be any fluid that can have its temperature safely altered to a predetermined temperature. Examples of such fluids include air and water. Once the fluid is within the fluid regulatory device, the fluid regulatory device alters the fluid's temperature to a predetermined temperature.
The predetermined temperature can be normothermic to the patient's present temperature, hypothermic to the patient's present temperature, and/or hyperthermic to the patient's present temperature. The method in which the fluid is altered to the predetermined temperature is known to those of ordinary skill in the art since Gaymar's Medi-Therm fluid regulatory device has been an industry standard for more than 10 years. Accordingly, the technology by which the fluid is maintained and/or adjusted to the predetermined temperature is clearly disclosed in the prior art.
The fluid having a predetermined temperature traverses through an inlet conduit from the fluid regulatory device to an inlet of the enclosure. The fluid circulates within the enclosure. The enclosure can be an open area or contain a channel that circulates the fluid in a predetermined direction.
The channel is formed by sealing and/or attaching a pre-selected portion of the first interior surface to a corresponding pre-selected portion of the second interior surface. The channel design can be serpentine, counter-clockwise, counter-serpentine, clockwise, random, finger-like projections, or combinations thereof. The objective of the channel is to maximize the chance that the fluid will transfer its thermal energy to the patient in an effective manner through the entire enclosure.
If the fluid is limited to air, the fluid can be released from the enclosure through apertures. The apertures direct the air having the predetermined temperature toward the patient. The use of apertures is referred to as a low-air loss embodiment. The low-air loss embodiment effectively transfers the gas' thermal energy to the patient. Thermoregulatory devices having apertures are also referred to as convective devices. An example of a convective device is Gaymar'S Thermacare blanket systems. Gaymar's Thermacare blanket systems have been publicly available since at least 1994.
If the fluid is a liquid, the liquid normally does not enter the enclosure having apertures. Apertures allow liquids to spill on the patient. Spilling liquids on a patient is undesirable. Normally, if the thermoregulatory device's enclosure contains an aperture when the fluid is a liquid, then the thermoregulatory device is normally thrown in the garbage.
Assuming the thermoregulatory device's enclosure receives a liquid and the enclosure has no apertures, the liquid's thermal energy transfers to the patient through the polymeric layer that contacts the patient. That thermal energy should alter and/or maintain the patient's temperature toward the predetermined temperature. Obviously, some thermal energy is lost when the thermal energy passes through the polymeric layer.
To address this loss of thermal energy in the non-apertured embodiment of the thermoregulatory device, it has been proposed to position a rivet-like device into the polymer layer that contacts the patient. The rivet-like device would have one end exposed to the liquid in the enclosure and the other end would be exposed to the exterior surface of the thermoregulatory device. In most instances, the rivet-like devices should have a greater conductivity than the polymeric layer. Thereby the fluid's thermal energy should transfer to the patient's skin at a higher rate of efficiency when compared to the conventional non-apertured polymeric thermoregulatory device.
A problem with the rivet-like device is the liquid normally leaks. Manufacturing a rivet containing thermoregulatory device has numerous quality control issues. It is difficult to manufacture a thermoregulatory device with numerous apertures and each aperture being filled with a rivet-type device that does not leak. As previously stated, a thermoregulatory device that leaks a liquid onto a patient is undesirable.